Resverlogix Corp. has announced that the first patient has been randomized and dosing has commenced in the Phase 3 clinical trial 'BETonMACE' with lead drug apabetalone (RVX-208) in high-risk patients with coronary artery disease (CAD) and type 2 diabetes mellitus (DM).
The primary outcome measure will assess the effect of apabetalone on time to first occurrence of Major Adverse Cardiovascular Events (MACE) in high-risk type 2 DM patients with CAD.
In the primary outcome measure, MACE is narrowly defined as a single composite endpoint of cardiovascular death, or non-fatal myocardial infarction (MI), or stroke. All subjects will remain on a high-dose statin therapy (atorvastatin or rosuvastatin), with the experimental group receiving 200 mg/day of apabetalone in the form of 100 mg capsules twice daily. Additional trial details and updates can be found at: www.clinicaltrials.gov and/or www.clinicaltrialsregister.eu/.
Dr. Michael Sweeney, senior vice president of clinical development stated, "We are pleased to announce that dosing has commenced in BETonMACE only two weeks after of the opening of our first sites. Every team member has worked exceptionally hard to expedite the process with rigorous attention to detail."